Log in
RegisterCheck in delay [GxP / QC / QA]
Dear Raghavendra,
OK
NOT OK
If the fasting condition is not maintained either at least 10 hours before dose or at least 4 hours post dose is a major deviation and your study might be questionable.
Regards
Raghavender.Chenna
❝ In a BA/BE study, on the day of check-in due to unavoidable reasons if the check-in happens late night say about 12midnight
OK
❝ is it ok with the restrictions and prohibitions mentioned in the protocol as they are going to file protocol deviation for the same. (eg: fasting restrictions of at least 10 hours before receiving the study drug?).
NOT OK
If the fasting condition is not maintained either at least 10 hours before dose or at least 4 hours post dose is a major deviation and your study might be questionable.
Regards
Raghavender.Chenna
Complete thread:
- Check in delay raghavendra_s 2010-02-18 06:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Check in delayraghu 2010-02-18 19:02
- Check in delay bharat 2010-03-09 07:05
Ing. Helmut Schütz